Regulatory

The FDA Is Phasing Out Animal Testing

As regulatory shifts accelerate, next-generation non-animal models must rapidly evolve to ensure safety, efficacy, and innovation in human drug development....

Rebuilding the Drug Repurposing Pipeline with Better Data

How high-quality, integrated datasets are transforming drug repurposing from opportunistic discovery to systematic innovation in therapeutic development. ...

Hesperos Unveils First Digital Twin of Human Disease with Organ-on-a-Chip Breakthrough

Landmark integration of in vitro organ-on-a-chip and computational modeling marks a pivotal advancement in disease simulation, drug testing, and personalized medicine....

Canada Grants Patent to bioAffinity Technologies for CyPath® Lung Diagnostic Test

New patent strengthens global IP portfolio for noninvasive lung cancer detection platform, expanding bioAffinity’s reach into international markets ...

Autonomix Medical Secures New U.S. Patent for Advancing Nerve-Targeted, Minimally Invasive Therapies

Patent strengthens company’s IP portfolio as it expands innovative treatments for chronic pain, oncology, and other high-need conditions ...

Takeda Secures FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices

New devices designed to streamline and personalize HYQVIA® administration for patients receiving subcutaneous immune globulin therapy...

Medtronic Earns CE Mark for Expanded Use of MiniMed™ 780G Insulin Pump System

Approval now includes children as young as two, pregnant individuals, and people with type 2 diabetes across Europe...

Spirair Secures FDA Clearance for TurbAlign™ Bioabsorbable Nasal Implant

Innovative device designed to maintain sinus patency post-surgery, enhancing healing and patient comfort without the need for removal...

Johnson & Johnson’s TAR-200 for Bladder Cancer Granted FDA Priority Review

NDA for TAR-200 targets high-risk non-muscle invasive bladder cancer, highlighting potential to transform treatment for patients unresponsive to BCG therapy...

Texas Cardiac Arrhythmia Institute Becomes First in U.S. to Use FDA-Approved Wireless System for Arrhythmia Treatment

St. David's Medical Center pioneers clinical use of innovative wireless EP solution, marking a new chapter in minimally invasive cardiac care....